DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The after final amendment filed August 17, 2026, has been received and entered.
Claims 2, 3, 6, 13-34, and 39 are cancelled.
Claims 1, 4, 5, 7-12, 35-38, 40, and 41 are pending and examined on the merits.
Response to Arguments
Applicant’s arguments, filed August 17, 2026, with respect to the objection to claims 1, 4, 5, 7-12, 40, and 41, the rejection under 35 U.S.C. 112(b) of claims 40 and 41, the rejection under 35 U.S.C. 103 of claims 13 and 14 as being unpatentable over Morris in view of Sakamoto, Muller, and Ashrafi, the nonstatutory double patenting rejection of claims 13 and 14 as being unpatentable over claims 1-16 of U.S. Patent No. 11,369,666 in view of Sakamoto, Muller, and Ashrafi, and the nonstatutory double patenting rejection of claims 13 and 14 as being unpatentable over claims 1-13 of U.S. Patent No. 11,364,286 in view of Sakamoto, Muller, and Ashrafi, have been fully considered and are persuasive.
Therefore, these objections and rejections have been withdrawn.
However, upon further consideration, a new grounds of rejection under 35 U.S.C. 112(a) is made. The finality of the Office Action mailed June 16, 2026, is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 5, 7-12, 35-38, 40, and 41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
There is insufficient written description for all microspheres having a diameter of between 30 and 700 micrometres that are adapted to elute the mucin-affecting protease over a period of time of between 5 hours and 120 hours, as recited in independent claims 1 and 35. Independent claim 1 recites that the microspheres consist of a hydrogel containing a solution comprising the mucin-affecting protease and a therapeutically effective amount of a thiol-containing mucolytic agent that reduces or disrupts disulfide bonds in mucins. Independent claim 35 recites that the microspheres comprise a hydrogel containing a solution comprising the mucin-affecting protease. None of the claims recite any further limitations describing the hydrogel, so the broadest reasonable interpretation of the hydrogel of the microspheres is any hydrogel.
MPEP 2163(II)(A)(3)(a)(ii) recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice…, reduction to drawings…, or by disclosure of relevant, identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.”
In the instant case, Applicant has not described the genus of the hydrogel comprised by the microspheres such that the specification might reasonably convey to the skilled artisan that Applicant had possession of the full scope of the claimed invention at the time the application was filed. Because the claims encompass a genus of variant species of the hydrogel of the microspheres, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species of the hydrogel by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus.
Regarding representative number of species, MPEP 2163(II)(A)(3)(a)(ii) states, “A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.” The species disclosed in the specification are: polyvinyl alcohol (PVA) hydrogel (e.g., DC Bead®; paragraph [0062]), poly(vinyl alcohol-co-sodium acrylate) hydrogel (e.g., HepaSphere™ Microspheres; paragraph [0063]), hydrogel core consisting of sodium poly(methacrylate) and an outer shell of poly(bis[trifluoroethoxy]phosphazene) (e.g., Embozene TANDEM™; paragraph [0064]), a hydrogel network of poly(ethylene glycol) and 3-sulfopropyl acrylate (paragraph [0066]), poly(lactic-co-glycolic acid) (PLGA) hydrogel network (paragraph [0066]), polylactic acid (PLLA) hydrogel network (paragraph [0066]). Therefore, the specification describes only six species. Six species of hydrogel is not a sufficient representative number of species for adequately describing the entire genus of hydrogel that, when comprised by microspheres having a diameter of between 30 and 700 micrometres, the microspheres are adapted to elute the mucin-affecting protease over a period of time of between 5 hours and 120 hours.
Regarding the identifying species, MPEP 2163(II)(A)(3)(a) states, “An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that inventor was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” Further still, MPEP 2163(II)(A)(3)(a)(ii) states, “For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” The specification does not explain what structural features of the hydrogel correlate with the elution of the mucin-affecting protease over a period of time of between 5 hours and 120 hours from microspheres having the claimed diameter. The six species of hydrogel disclosed in the specification are diverse such that there is insufficient identifying characteristics regarding the hydrogel to provide evidence that the inventor was in possession of the full broad scope of the claimed hydrogel that, when comprised by microspheres of the claimed diameter, the microspheres are in turn adapted to elute the mucin-affecting protease as claimed. The specification does not describe all other members of the claimed genus by complete structure. Therefore, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. As such, the Applicant was not in possession of the claimed genus of hydrogel. The claimed subject matter is not fully supported by an adequate written description because a representative number of species has not been described.
In sum, while there is written description for the hydrogel of paragraphs [0062]-[0064] and [0066] as the hydrogel of the microspheres adapted to elute the mucin-affecting protease over a period of time of between 5 hours and 120 hours, adequate written description is lacking to demonstrate possession of the full scope of microspheres as recited in the claims.
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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